JB-1002 - Senior Executive - Regulatory Affairs

Premier Inn Hotels LLC (UAE); Dehradun; Remote; INR 900,000 - 1,400,000; Full time

Job summary

Rhydburg Biotech Ltd. is seeking a Senior Executive - Regulatory Affairs to lead analytical method validation review, ensure CTD Module 3 alignment, and support regulatory queries for APIs and finished products.

Requires a Bachelor’s or Master’s degree in Pharmacy and at least three years in QC/QA/R&D or analytical validation, with hands-on experience and strong ICH and pharmacopeial knowledge. Remote work is available with defined review responsibilities.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy is mandatory.
• Minimum three years in QC, QA or R&D or analytical validation roles.
• Hands-on experience reviewing analytical method validation documentation.
• Sound working knowledge of ICH guidelines and pharmacopeial standards.
• Strong analytical data interpretation and technical documentation review skills.
• Remote working option with defined review responsibilities.
• Flexible working hours aligned to dossier and submission timelines.
• High technical ownership without laboratory or shop-floor operations.

Responsibilities

• Review analytical methods for APIs and finished pharmaceutical products.
• Review analytical method validation protocols and validation study reports.
• Review API and finished product specifications, limits, and acceptance criteria.
• Review stability study data and shelf-life justifications in line with ICH guidelines.
• Review DMF analytical sections and critical API quality attributes for compliance.
• Verify analytical compliance for BE study sample testing and reporting activities.
• Identify analytical documentation gaps impacting regulatory acceptability.
• Support preparation of analytical-related responses to regulatory authority queries.
• Verify alignment of analytical data with CTD Module 3 structure and expectations.
• Maintain accuracy, traceability, version control, and integrity of analytical records.

Skills

Analytical data interpretation

Technical documentation review

ICH guidelines knowledge

Education

Bachelor’s or Master’s degree in Pharmacy

Job description

JB-1002 - Senior Executive - Regulatory Affairs

• Industry Pharma/Biotech/Clinical Research

About Us

Rhydburg Biotech Ltd. is a manufacturer, marketer and exporter of pharmaceutical generic products. The organisation's core strength is its strong Research and Development and Regulatory capabilities. The organisation aims to build strong presence in the public and private drug distribution systems through high-quality products.

Job Description

Job Description

Review analyticalmethods for APIs and finished pharmaceutical products.

Review analyticalmethod validation protocols and validation studyreports.

Review API andfinished product specifications, limits, and acceptancecriteria.

Review stabilitystudy data and shelf-life justifications in line with ICHguidelines.

Review DMF analyticalsections and critical API quality attributes forcompliance.

Verify analyticalcompliance for BE study sample testing and reportingactivities.

Identify analyticaldocumentation gaps impacting regulatory acceptability.

Support preparationof analytical-related responses to regulatory authorityqueries.

Verify alignment ofanalytical data with CTD Module 3 structure andexpectations.

Maintain accuracy,traceability, version control, and integrity of analyticalrecords.

Requirements

Bachelor’s orMaster’s degree in Pharmacy is mandatory.

Minimum three yearsexperience in QC, QA or R&D or analytical validationroles.

Hands-on experiencereviewing analytical method validation documentation.

Sound workingknowledge of ICH guidelines and pharmacopeialstandards.

Strong analyticaldata interpretation and technical documentation reviewskills.

Remote working optionwith defined review responsibilities.

Flexible workinghours aligned to dossier and submission timelines.

High technicalownership without laboratory or shop-floor operations.